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CELL MARQUE CORPORATION

United States·US-MF-000028332

Last updated September 17, 2026

Information

Country: United States
Address: 6600, Sierra College Blvd, Rocklin, United States
Website: cellmarque.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 916 746 8900
PRRC Contact: Cheryl Prichard
EUDAMED SRN: US-MF-000028332
FDA FEI Number: 3017212430
DUNS Number: 025048773

Catalogue (2151)

Page 8 of 44

Device	Model / Reference	Registries	Class	Status
IgG4 (MRQ-44) Mouse Monoclonal Antibody	367M-17	FDA UDI	Class I	Active
PSA (ER-PR8) Mouse Monoclonal Antibody	760-4271	FDA UDI	Class I	Active
Napsin A (EP205) Rabbit Monoclonal Primary Antibody	352R-16	FDA UDI	Class I	Active
IgG4 (MRQ-44) Mouse Monoclonal Antibody	367M-15	EUDAMEDFDA UDI	Class I	Active
TdT (EP266) Rabbit Monoclonal Primary Antibody	338R-27	FDA UDI	Class I	Active
Herpes Simplex Virus II (3C5.2) Mouse Monoclonal Antibody	362M-14-ASR	FDA UDI	Class I	Active
CD5 (SP19) Rabbit Monoclonal Antibody	205R-14	FDA UDI	Class I	Active
L1 (Cytoactiv) Mouse Monoclonal Antibody	498M-15-ASR	FDA UDI	Class I	Active
CD61 (EP65) Rabbit Monoclonal Primary Antibody	161R-18	FDA UDI	Class I	Active
FOXA1 (2F83) Mouse Monoclonal Antibody	405M-14	FDA UDI	Class I	Active
Cathepsin K (3F9) Mouse Monoclonal Antibody	402M-15	FDA UDI	Class I	Active
CD23 (MRQ-57) Mouse Monoclonal Antibody	123M-26	FDA UDI	Class I	Active
EMA (E29) Mouse Monoclonal Antibody	247M-94	FDA UDI	Class I	Active
Helicobacter pylori Rabbit Polyclonal Antibody	215A-70-ASR	FDA UDI	Class I	Active
SV40 (MRQ-4) Mouse Monoclonal Antibody	351M-17-ASR	FDA UDI	Class I	Active
CD35 (EP197) Rabbit Monoclonal Primary Antibody	135R-14	FDA UDI	Class I	Active
PU.1 (EPR3158Y) Rabbit Monoclonal Primary Antibody	328R-14	FDA UDI	Class I	Active
Gastrin Rabbit Polyclonal Antibody	256A-18	FDA UDI	Class I	Active
MAGEC2 (EP405) Rabbit Monoclonal Primary Antibody	477R-16	FDA UDI	Class I	Unknown
Herpes Simplex Virus I Rabbit Polyclonal Antibody	361A-15-ASR	FDA UDI	Class I	Active
Smoothelin (R4A) Mouse Monoclonal Antibody	377M-14	FDA UDI	Class I	Active
S100 beta (EP32) Rabbit Monoclonal Primary Antibody	449R-15	FDA UDI	Class I	Active
EGFR (SP84) Rabbit Monoclonal Antibody	414R-14-ASR	FDA UDI	Class I	Active
Adenovirus (20/11 & 2/6) Mouse Monoclonal Antibody	212M-14-ASR	FDA UDI	Class I	Active
Estrogen Receptor (SP1) Rabbit Monoclonal Antibody	249R-18-ASR	FDA UDI	Class I	Active
Oct-2 (MRQ-2) Mouse Monoclonal Antibody	308M-14	FDA UDI	Class I	Active
CD4 (EP204) Rabbit Monoclonal Primary Antibody	104R-27	FDA UDI	Class I	Active
Her2/Neu (EP3) Rabbit Monoclonal Primary Antibody	237R-26-ASR	FDA UDI	Class I	Active
Cytokeratin 5 & 6 (D5 & 16B4) Mouse Monoclonal Antibody	356M-15	FDA UDI	Class I	Active
CD7 (MRQ-56) Mouse Monoclonal Antibody	107M-25	FDA UDI	Class I	Active
IgA (EP170) Rabbit Monoclonal Primary Antibody	267R-14	FDA UDI	Class I	Active
C3d Rabbit Polyclonal Antibody	760-4522	FDA UDI	Class I	Active
IgG Rabbit Polyclonal Antibody	760-2653	FDA UDI	Class I	Active
ERG (EP111) Rabbit Monoclonal Primary Antibody	434R-15	FDA UDI	Class I	Active
Thyroglobulin (MRQ-41) Mouse Monoclonal Antibody	340M-96	FDA UDI	Class I	Active
CD20 (SP32) Rabbit Monoclonal Antibody	120R-15	FDA UDI	Class I	Active
IgG4 (MRQ-44) Mouse Monoclonal Antibody	760-4614	EUDAMEDFDA UDI	Class I	Active
HGAL (MRQ-49) Mouse Monoclonal Antibody	375M-96	FDA UDI	Class I	Active
CD13 (EP117) Rabbit Monoclonal Primary Antibody	113R-28	FDA UDI	Class I	Active
MLH1 (M1) Mouse Monoclonal Antibody	285M-25-ASR	FDA UDI	Class I	Active
Perforin (MRQ-23) Mouse Monoclonal Antibody	316M-14	FDA UDI	Class I	Active
MLH1 (G168-728) Mouse Monoclonal Antibody	285M-14-ASR	FDA UDI	Class I	Active
CD4 (EP204) Rabbit Monoclonal Primary Antibody	104R-24	FDA UDI	Class I	Active
PGP 9.5 Rabbit Polyclonal Antibody	318A-14	FDA UDI	Class I	Active
Mammaglobin (31A5) Rabbit Monoclonal Antibody	280R-15	FDA UDI	Class I	Active
IgA Rabbit Polyclonal Antibody	267A-14	FDA UDI	Class I	Active
GCDFP-15 (EP1582Y) Rabbit Monoclonal Primary Antibody	257R-16	FDA UDI	Class I	Active
Human Placental Lactogen (hPL) Rabbit Polyclonal Antibody	266A-16	FDA UDI	Class I	Active
TROP2 (EP431) Rabbit Monoclonal Primary Antibody	465R-17	FDA UDI	Class I	Active
C3d Rabbit Polyclonal Antibody	403A-76	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (18)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jul 15, 2021	Z-2311-2021	—	open, classified	Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest.
May 27, 2021	Z-2105-2021	—	terminated	Product distributed for use as an In-vitro Diagnostics without FDA clearance
May 27, 2021	Z-2106-2021	—	terminated	Product distributed for use as an In-vitro Diagnostics without FDA clearance
May 5, 2017	Z-2204-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2209-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2203-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2199-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2200-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2205-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2202-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2201-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2207-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2206-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2210-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 5, 2017	Z-2208-2017	—	terminated	Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
May 10, 2016	Z-2038-2016	—	terminated	Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result.
Jan 23, 2012	Z-1176-2012	—	terminated	Letter received from supplier that material received in October 2009 was labeled as CD7, but was actually CD 2.
Jul 12, 2011	Z-3110-2011	—	terminated	Incorrect label on product bottle, although labeling on outer box is correct.